Myovant's relugolix meets in Phase III for uterine fibroids

Myovant Sciences GmbH (NYSE:MYOV) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said relugolix (TAK-385) met the primary endpoint of non-inferiority to leuprorelin acetate in reducing menstrual bleeding in the Japanese Phase III TAK-385/CCT-002 trial to treat symptomatic uterine fibroids. Myovant said Takeda expects to report top-line data from a second Japanese Phase III trial of relugolix in women with pain associated with uterine fibroids this quarter, after which the pharma plans to submit the data from both trials to Japanese regulatory authorities for relugolix to treat uterine fibroids.

On the primary endpoint, once-daily 40 mg oral relugolix for 24 weeks was non-inferior to leuprorelin acetate in the proportion of patients who achieved a total score of <10 points on the Pictorial Blood Loss Assessment Chart, a patient-reported outcome measure to assess menstrual blood loss, from week 6 to week 12 (82.2% vs. 83.1%, p=0.0013 for non-inferiority). The trial enrolled about 280 women with heavy menstrual bleeding associated with uterine fibroids. Secondary endpoints in the double-blind trial include myoma and uterine volume, hemoglobin, numerical rating scale (NRS) pain score, Uterine Fibroid Symptom and Quality of Life (UFS-QOL) score and safety...